Class 2 Device Recall MEDLINE

• Date Initiated by Firm: April 05, 2024
• Date Posted: May 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2098-2024
• Recall Event ID: 94520
• Product Classification: Syringe, piston - Product Code FMF
• Product: Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
• Code Information: Lot Code: LOT: 63720120007,63721110003,63721120004,63722010 001,63722020002,63722030002,63722060003, 63722070002,63723100003,63723110005,63723120 002
• Recalling Firm/ Manufacturer: Jiangsu Shenli Medical Production Co., Ltd.; No. 20 Changzheng Road; Zhengluzhen Wujin; Changzhou China
• For Additional Information Contact: Liqun Yang; +8651988731071
• Manufacturer Reason for Recall: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
• FDA Determined Cause: No Marketing Application
• Action: On 05/14/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that Jiangsu Shenli Medical Production Co., Ltd. is recalling piston syringes that were distributed without premarket clearance. The Recalling Firm stated that they received an FDA Warning Letter that the piston syringes were not legally marketed devices. Customers are instructed to: Examine their inventory and stop/cease use of all syringe products subject to this action and report the inventory quantity to Jiangsu Shenli Medical Production Co., Ltd. Considering the complicated return process, and high cost of returning the products, the firm is instructing customers to dispose of these recalled syringes in the U.S, using their facility s approved/established procedures for disposal of medical products, or by contacting a local third party company to assist with the disposal of the recalled syringes. Please report the destruction method and cost with Shenli before final implementation. After product disposal, please provide Shenli with confirmation of destruction of products. For questions or assistance - contact the general manager at email shenli@syringechina.com or telephone number 0086-519-88731071
• Quantity in Commerce: 44800
• Distribution: U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.